Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

QVN · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.3410

Classification

FDA Product Code: QVN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 874.3410
Review panel: EN
Medical specialty: Ear, Nose, Throat
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown